The Medical Device Business Journal — Medical Device News & Articles | MassDevice
California-based medical device maker Avinger landed FDA clearance for its Ocelot | PIXL catheter system, the company’s 2nd FDA win in as many months.
In November Avinger won clearance to commercialize its Ocelot System, designed to help physicians see inside arteries to treat peripheral artery disease.
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The FDA cleared Avinger’s Ocelot System, a medical device that allows physicians to see images from inside arteries in a treatment of peripheral artery disease.
The Ocelot catheter, supported by the company’s Lightbox imaging console, is designed with real-time optical coherence tomography to help operators accurately navigate through crossing chronic total occlusions.
Merck Global Health Innovation Fund will invest up to $17 million in medical app maker Physicians Interactive Holdings. The financing includes $8.5 million up front, but could double if the mHealth marketer meets Merck’s milestones.
The Marlborough, Mass.-based company plans to use the Merck funds to grow "4 key products," including its flagship medical resources app Skyscape.
Calgary Scientific’s ResolutionMD mobile got a green light from the FDA for viewing diagnostic images on iPhones and iPads.
The ResolutionMD mobile app was built from existing ResolutionMD software, which recieved FDA clearance in 2006. The app already has the greenlight from Canada’s regulatory body, Health Canada and has a CE Mark for distribution in Europe.
Avinger Receives CE Mark Approval for Its Ocelot Catheter That Incorporates Real-Time Intravascular Guidance Using Optical Coherence Tomography (OCT)
CEO John B. Simpson, PhD, MD, will begin commercial use of Ocelot to treat patients in Europe for Peripheral Artery Disease
REDWOOD CITY, Calif., Sep 26, 2011 (BUSINESS WIRE) — Avinger, Inc. announced today that it has received CE Mark approval for Ocelot — a system that combines the use of Avinger’s proprietary peripheral catheter designs incorporated with real-time Optical Coherence Tomography (OCT) for the treatment of Peripheral Artery Disease (PAD).
Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European for its percutaneous aortic valve replacement system, CoreValve.
The device is "the only transcatheter aortic valve available in the world that can treat – without surgery – patients with larger valve openings (up to 29mm)," according to a press release.
CoreValve is the largest transcatheter valve available, but can compress into a small delivery system to be deployed in the same delivery system as smaller CoreValve sizes.
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.
